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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.
Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.
Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | Subjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed. |
|
| Rehabilitation | Active Comparator | Subjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Aerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to claudication pain | Time to initial onset of claudication pain with exercise treadmill test. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak VO2 | Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| 6-minute walk test (6MWT) |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | The Endo Pat 2000 system will be used to perform this procedure. Both forearms will be occluded with a standard blood pressure cuff for 5 minutes. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Ankle-brachial index (ABI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan N Myers, PhD | Contact | 650-493-5000 | 64661 | drj993@aol.com |
| Charles G Gronau, DCEP | Contact | 618-746-69565 | gronauc92@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Recruiting | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26089368 | Background | Correction. Circ Res. 2015 Jun 19;117(1):e12. doi: 10.1161/RES.0000000000000059. No abstract available. | |
| 15113781 | Background | Mayfield JA, Reiber GE, Maynard C, Czerniecki J, Sangeorzan B. The epidemiology of lower-extremity disease in veterans with diabetes. Diabetes Care. 2004 May;27 Suppl 2:B39-44. doi: 10.2337/diacare.27.suppl_2.b39. |
| Label | URL |
|---|---|
| U.S. Markets for Peripheral Vascular Stents | View source |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Prehabiliation and Rehabilitation | Experimental | Subjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions. |
|
|
| VAPAHCS Rehabilitation Core Components | Other | The prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal. |
|
Total distance (meters) of walk in 6 minutes.
| Baseline, 6 weeks, 14 weeks, 22 weeks |
| Walking Impairment Questionnaire (WIQ) | Developed to evaluate walking limitations in patients with PAD. Assesses the ability of individuals to walk defined distances and speeds and climb stairs. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Peripheral Artery Questionnaire (PAQ) | 20-item questionnaire developed and validated specifically for PAD and is designed to quantify patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Walking | Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device. | Up to 22 weeks |
| Energy expenditure | Energy expenditure will be quantified using fitness/health tracking device. | Up to 22 weeks |
| Chair raises | Number of repetitions completed within 60 seconds (46cm high seat). | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Upper body strength | 1 repetition max for Chest Press. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Lower body strength | 1 repetition max for Leg Extension. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Hand grip strength | Maximum isometric strength will be measured using a hand grip dynamometer. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Insulin sensitivity | Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Lipid panel | Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Sodium | Standard Chem 20 blood draw will be used to obtain sodium in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Homocysteine | Homocysteine will be assessed from blood draw. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| High-sensitivity C-reactive protein (hs-CRP) | High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6) will be assessed from blood draw. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| D-dimer | D-dimer will be assessed from blood draw. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Blood protein | Blood draw will be used to obtain blood protein value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Albumin | Blood draw will be used to obtain albumin in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Calcium | Blood draw will be used to obtain calcium in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Potassium | Blood draw will be used to obtain potassium in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Chloride | Blood draw will be used to obtain chloride in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Carbon dioxide | Blood draw will be used to obtain carbon dioxide in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| AST/GOTU/l | Blood draw will be used to obtain AST/GOTU/l in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| ALT/GPT | Blood draw will be used to obtain ALT/GPT in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| ALK Phosphatase | Blood draw will be used to obtain ALT/GPT in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Bilirubin | Blood draw will be used to obtain total bilirubin in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Urea Nitrogen | Blood draw will be used to obtain urea nitrogen in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| Creatinine | Blood draw will be used to obtain creatinine in blood value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
| eGFR | Blood draw will be used to obtain eGFR value. | Baseline, 6 weeks, 14 weeks, 22 weeks |
Using a standard brachial artery cuff method with a Doppler ultrasound probe at the posterior tibial artery to determine ABI.
| Baseline, 6 weeks, 14 weeks, 22 weeks |
| Exercise Benefits and Barriers Scale (EBBS) | Perceived barriers and benefits to physical activity will be assessed using two methods: a semi-structured interview and administration of the Exercise Benefits and Barriers Scale (EBBS), to obtain both open-ended qualitative and quantitative data on these constructs. The EBBS may be used in its entirety or as two seperate scales. As a whole, scoring for EBBS ranges from 43 to 172 with a higher score being the individual perceives exercise more positively. When the Benefits Scale is used alone, the score range is between 29 to 116 with the higher the score being the individual perceives exercise more positively. When the Barriers Scale is used alone, the score range is between 14 to 56. The higher the score on the Barriers Scale, the greater the perception of barriers to exercise. | Baseline, 6 weeks, 14 weeks, 22 weeks |
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| 31208829 | Background | Sun V, Raz DJ, Kim JY, Melstrom L, Hite S, Varatkar G, Fong Y. Barriers and facilitators of adherence to a perioperative physical activity intervention for older adults with cancer and their family caregivers. J Geriatr Oncol. 2020 Mar;11(2):256-262. doi: 10.1016/j.jgo.2019.06.003. Epub 2019 Jun 14. |
| 33389812 | Background | Birtwistle SB, Jones I, Murphy R, Gee I, Watson PM. Family support for physical activity post-myocardial infarction: A qualitative study exploring the perceptions of cardiac rehabilitation practitioners. Nurs Health Sci. 2021 Mar;23(1):227-236. doi: 10.1111/nhs.12806. Epub 2021 Jan 26. |
| 22291128 | Background | Arena R, Williams M, Forman DE, Cahalin LP, Coke L, Myers J, Hamm L, Kris-Etherton P, Humphrey R, Bittner V, Lavie CJ; American Heart Association Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Council on Nutrition, Physical Activity and Metabolism. Increasing referral and participation rates to outpatient cardiac rehabilitation: the valuable role of healthcare professionals in the inpatient and home health settings: a science advisory from the American Heart Association. Circulation. 2012 Mar 13;125(10):1321-9. doi: 10.1161/CIR.0b013e318246b1e5. Epub 2012 Jan 30. No abstract available. |
| 30586765 | Background | Treat-Jacobson D, McDermott MM, Bronas UG, Campia U, Collins TC, Criqui MH, Gardner AW, Hiatt WR, Regensteiner JG, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019 Jan 22;139(4):e10-e33. doi: 10.1161/CIR.0000000000000623. No abstract available. |
| 20863958 | Background | American Association of Cardiovascular and Pulmonary Rehabilitation; American College of Cardiology Foundation; American Heart Association Task Force on Performance Measures (Writing Committee to Develop Clinical Performance Measures for Cardiac Rehabilitation); Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J. AACVPR/ACCF/AHA 2010 Update: Performance Measures on Cardiac Rehabilitation for Referral to Cardiac Rehabilitation/Secondary Prevention Services Endorsed by the American College of Chest Physicians, the American College of Sports Medicine, the American Physical Therapy Association, the Canadian Association of Cardiac Rehabilitation, the Clinical Exercise Physiology Association, the European Association for Cardiovascular Prevention and Rehabilitation, the Inter-American Heart Foundation, the National Association of Clinical Nurse Specialists, the Preventive Cardiovascular Nurses Association, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2010 Sep 28;56(14):1159-67. doi: 10.1016/j.jacc.2010.06.006. No abstract available. |
| 9133516 | Background | Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Vogt P, Ratti R, Muller P, Miettunen R, Buser P. Effect of exercise training on myocardial remodeling in patients with reduced left ventricular function after myocardial infarction: application of magnetic resonance imaging. Circulation. 1997 Apr 15;95(8):2060-7. doi: 10.1161/01.cir.95.8.2060. |
| 9180124 | Background | Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Muller P, Buser P, Stulz P, Vogt P, Ratti R. Effect of high intensity exercise training on central hemodynamic responses to exercise in men with reduced left ventricular function. J Am Coll Cardiol. 1997 Jun;29(7):1591-8. doi: 10.1016/s0735-1097(97)82540-5. |
| 30797041 | Background | Myers J, Fonda H, Vasanawala M, Chung K, Segall G, Chan K, Nguyen P. PCI Alternative Using Sustained Exercise (PAUSE): Rationale and trial design. Contemp Clin Trials. 2019 Apr;79:37-43. doi: 10.1016/j.cct.2019.02.010. Epub 2019 Feb 20. |
| 36099058 | Background | Campbell EB, Delgadillo M, Lazzeroni LC, Louras PN, Myers J, Yesavage J, Fairchild JK. Cognitive Improvement Following Physical Exercise and Cognitive Training Intervention for Older Adults With MCI. J Gerontol A Biol Sci Med Sci. 2023 Mar 1;78(3):554-560. doi: 10.1093/gerona/glac189. |
| Background | Moore CS, Myers J, Yesavage JA, Fairchild JK. Ventilatory efficiency is associated with memory decay in older adults with amnestic mild cognitive impairment. Submitted, 2022 |
| Background | Moore CS, Myers J, Yesavage JA, Fairchild JK. Assessment of physical activity in older adults with cognitive impairment. Submitted, 2022 |
| Background | Fairchild JK, Myers J, Louras P, Jo B, McNerney MW, Salehi A, Hallmayer J, Yesavage J. A Combined physical and cognitive training program for veterans with mild cognitive impairment: A randomized clinical trial. Submitted, 2022. |
| Related Info | View source |
| Bloom E. Prehabilitation evidence and insight review. Macmillan National Cancer Rehabilitation, 2018. | View source |
| Centers for Medicare \& Medicaid Services. Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease | View source |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |